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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tampon, menstrual, unscented
510(k) Number K223749
Device Name U by Kotex® Click® Unscented Menstrual Tampons
Applicant
Kimberly-Clark Corporation
2100 Winchester Road
Neenah,  WI  54956
Applicant Contact Jeremy Paulsen
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/14/2022
Decision Date 01/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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